Assessing the usability of wireless thermal devices for hydrocephalus management
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Rhaeos, Inc. · NCT06040697
This study is testing a new wireless device that measures fluid flow in people with hydrocephalus to see how easy it is to use and understand.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Ages | 5 Years to 80 Years |
| Sex | All |
| Sponsor | Rhaeos, Inc. (industry) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06040697 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on evaluating the usability of wireless thermal anisotropy devices designed for measuring shunt flow in patients with hydrocephalus. Participants will undergo non-invasive measurements while their interactions with the device are observed, and their understanding will be assessed through comprehension questions. The data collected will inform future improvements in device design to enhance patient care and usability.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 to 80 years with an existing ventricular CSF shunt and intact skin over the shunt catheter.
Not a fit: Patients with open wounds in the device application area or those with a history of adverse skin reactions to adhesives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved device designs that enhance the management of hydrocephalus.
How similar studies have performed: While this approach is innovative, similar studies assessing usability in medical devices have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device 2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 3. Subject or caregiver can clearly communicate and document information in English 4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision 5. Subject is at least 5 years old but not more than 80 years old Exclusion Criteria: 1. Presence of an interfering open wound in the device application region 2. Subject-reported history of adverse skin reactions to adhesives
Where this trial is running
Chicago, Illinois
- Rhaeos, Inc. — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Anna Somera
- Email: info@rhaeos.com
- Phone: 855-814-3569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hydrocephalus